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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0455-2013

Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.

Publicado el 12 de diciembre de 2012 · Inicio del retiro: 24 de mayo de 2011

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Stryker Instruments Div. of Stryker Corporation
Distribuidor
Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
Lote
Part 0702-002-000 (230v) Lot 0733700353 through 1036100423
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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